Effectiveness of Brief Mindfulness-Based Interventions for Painful Temporomandibular Disorders Among University Students

NCT06582134 | Recruiting

• 1 other identifier: DF OS2309/0063 (P)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if brief mindfulness-based intervention (BMBI) is beneficial to participants suffering from painful temporomandibular disorders (TMD). The objectives of the research are:

1. 1.To compare physical functioning (pain intensity and jaw function) in UM students with chronic pain-related TMD before and after receiving BMBI
2. 2.To compare psychological distress and mindfulness state in UM students with chronic pain-related TMD before and after receiving BMBI
3. 3.To compare the quality of life of UM students with chronic pain-related TMD before and after receiving BMBI
4. 4.To compare the changes in physical functioning, psychological distress, mindfulness state and quality of life between UM students in the intervention (BMBI) and the control groups.

Conditions

Temporomandibular Disorders; Chronic Pain

Keywords

Brief mindfulness-based intervention; Temporomandibular disorders; University students

Outcome Measures

Primary Outcomes (4)

• Degree of Pain Intensity

  * Graded Chronic Pain Scale Version 2.0 (GCPS v2) * 3 items for Characteristic Pain Intensity (CPI), 4 items for Interference Score and 1 item for Disability points for number of days with interference * CPI and Interference Scores are derived from computed mean of items, multiply by 10 * Disability points for number of days with interference is determined from assigned points in a designated table * Total Disability Points = points for Disability Days + points for Interference Score * CPI and Disability Points will determine chronic pain grade (1=none; I=low intensity pain, without disability; II=high intensity pain, without disability; III- moderately limiting; IV=severely limiting)

  Change from Baseline at 2 weeks, 1 month and 3 Months

• Degree of Limitation of Jaw Function

  * Jaw Function Limitation Scale (JFLS-8) questionnaire * 8-item global scale for overall functional limitation of the masticatory system * Each item is rated on a numerical rating scale of 0 to 10 (0 indicates no limitation; 10 indicates severe limitation) * Mean of available items will determine degree of limitation

  Change from Baseline at 2 weeks, 1 month and 3 Months

• Level of Psychological distress

  * Psychological Distress (PHQ-4) questionnaire * 4 items, each with scores ranging from 0 (not at all) to 3 (nearly every day) * total score ≤2 indicates none-to-minimal levels of depression or anxiety, 3 to 5 indicates mild levels, 6 to 8 indicates moderate levels and ≥9 indicates severe levels

  Change from Baseline at 2 weeks, 1 month and 3 Months

• Extent of Impact on Oral-health Related Quality of Life

  * Oral Health Impact Profile-TMD (OHIP-TMD-22) * 22 items tool assessing oral health-related quality of life specific to TMD * Responses are scored from 0-4: never (0), hardly ever (1), occasionally (2), often(3), and very often (4) * Sum of scores ranges from 0 to 88 points, with higher scores indicating poorer quality of life

  Change from Baseline at 2 weeks, 1 month and 3 Months

Secondary Outcomes (1)

• Mindfulness state

  Change from Baseline at 2 weeks, 1 month and 3 Months

Other Outcomes (2)

• Width of Mouth Opening

  Change from Baseline at 2 weeks, 1 month and 3 Months

• Number of Palpation Sites With Pain

  Change from Baseline at 2 weeks, 1 month and 3 Months

Study Arms (2)

Control

SHAM COMPARATOR

Three 10-minute audio recordings (1, 2, 3) in MPEG-1 Audio Layer 3 (MP3) format consisting of relaxing music that mimic BMBI in duration but do not contain instructions specific to mindfulness training.

Behavioral: Sham BMBI

Brief Mindfulness-Based Intervention

EXPERIMENTAL

Three 10-minute audio recordings (A,B,C) for BMBI in MPEG-1 Audio Layer 3 (MP3) format that contain mindfulness training based on the breathing concept in a background of relaxing music.

Behavioral: BMBI

Interventions

Sham BMBI BEHAVIORAL

Participants are requested to listen to the recordings 3 times a week, for 3 months (in a standardized sequence e.g., 1-2-3 and repeat) on Mondays-Wednesdays-Fridays. They are instructed to listen right before they sleep and encouraged to use them whenever they feel stressed or in pain.

Control

BMBI BEHAVIORAL

Participants are requested to listen to the recordings 3 times a week, for 3 months (in a standardized sequence e.g. A-B-C and repeat) on Mondays-Wednesdays-Fridays. They are instructed to listen right before they sleep and encouraged to use them whenever they feel stressed or in pain.

Brief Mindfulness-Based Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Students attending Universiti Malaya
• Able to read and understand English.
• Willing and able to give informed consent.
• Score 3 and above on the TMD-PS, for at least 3 months.

You may not qualify if:

• Hearing impairment.
• Currently on psychiatric follow up and/or taking psychotropic prescriptions (antidepressants, anti-anxiety medications, stimulants, antipsychotics, and mood stabilizers).
• Experience with activities similar to the intervention such as meditation, yoga or tai chi.
• Currently practicing some form of mindfulness meditation.
• History of orofacial trauma, craniofacial pathology, and previous orofacial surgeries (including orthognathic and TMJ)
• Systemic rheumatic, neurologic/neuropathic, endocrine (e.g., diabetes mellitus) or immune / autoimmune diseases or widespread pain or being treated with immunosuppressant drugs
• Non-TMD orofacial pain disorders
• Radiation treatment to head and neck.
• Use of narcotic pain medication, muscle relaxants or steroid therapy unless discontinued 1 week before enrolment to study
• Use of nonsteroidal anti-inflammatory medications unless the medication(s) were discontinued for 3 days prior to enrolment (use of acetaminophen is allowed as a rescue drug)
• Currently on antibiotics or taken antibiotics within the last 2 weeks prior to start of study
• Currently pregnant or lactating women

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Oral Medicine Clinic, Faculty of Dentisty, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (6)

• Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.

  PMID: 33884400 BACKGROUND

• McClintock AS, McCarrick SM, Garland EL, Zeidan F, Zgierska AE. Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. J Altern Complement Med. 2019 Mar;25(3):265-278. doi: 10.1089/acm.2018.0351. Epub 2018 Dec 5.

  PMID: 30523705 BACKGROUND

• Schumer MC, Lindsay EK, Creswell JD. Brief mindfulness training for negative affectivity: A systematic review and meta-analysis. J Consult Clin Psychol. 2018 Jul;86(7):569-583. doi: 10.1037/ccp0000324.

  PMID: 29939051 BACKGROUND

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

• Yule PL, Durham J, Playford H, Moufti MA, Steele J, Steen N, Wassell RW, Ohrbach R. OHIP-TMDs: a patient-reported outcome measure for temporomandibular disorders. Community Dent Oral Epidemiol. 2015 Oct;43(5):461-70. doi: 10.1111/cdoe.12171. Epub 2015 Jun 4.

  PMID: 26040190 BACKGROUND

• Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and perceived stress in a mindfulness-based stress reduction program. J Clin Psychol. 2012 Jul;68(7):755-65. doi: 10.1002/jclp.21865. Epub 2012 May 23.

  PMID: 22623334 BACKGROUND

Related Links

• Diagnostic Criteria for Temporomandibular Disorders: Scoring Manual for Self-Report Instruments.

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathreena Kadir, MClinDent (OMFS)(Mal)

  Faculty of Dentistry, Universiti Malaya

  STUDY CHAIR

Central Study Contacts

Siew Wui Chan, MClinDent (UM)

CONTACT

+60-379674540; swuichan@um.edu.my

Zuraiza Mohamad Zaini, MRACDS (Oral Med), PHD(London)

CONTACT

+60-379674869; zuraiza@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 3, 2024
• Study Start: January 12, 2024
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)